Wednesday, July 8, 2026
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Drug profile · INN

methotrexate

ARX-METHOTREXATE

methotrexate (ARX-METHOTREXATE) is a dihydrofolate reductase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AX03
US status approved
Patents linked 10
Pipeline programs 54
News articles 0
Drug details — methotrexate
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
10
Programs
54
Data quality
0.84
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Quick answer

methotrexate (ARX-METHOTREXATE) is a dihydrofolate reductase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN methotrexate
Brand ARX-METHOTREXATE
Mechanism Dihydrofolate reductase inhibitor
Target Dihydrofolate reductase
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation SOLUTION
ATC code L04AX03
Originator Pfizer Australia Pty Ltd

Mechanism of action

Dihydrofolate reductase inhibitor

Primary target: Dihydrofolate reductase

Approval history

Authority Status Date
FDA approved —
EMA approved —
TGA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline Sponsor programs
  1. 042011 Phase 3 · George Institute for · Langerhans Cell Histiocytosis
  2. 20190360 Phase 3 · Amgen · Newly diagnosed Philadelphia-negative B-cell precursor Acute
  3. AB-01-004 Phase 3 · Dr. Reddy's Laboratories · Rheumatoid Arthritis
  4. ADX-2191 (intravitreal methotrexate 0.8%) Phase 3 · Aldeyra Therapeutics · Proliferative Vitreoretinopathy
  5. ALL2820 Phase 3 · Telethon Foundation · Adult Philadelphia Chromosome-Positive Acute Lymphoblastic L
  6. APHP200026 Phase 3 · PARItec · Patients with GPA and inadequate response to standard of car
  7. APHP240920 Phase 3 · PARItec · Cutaneous lupus erythematosus
  8. C0251010 Phase 3 · First Biotech (Australia) · Idiopathic Inflammatory Myopathy (including dermatomyositis

Related & competitor drugs

Browse all drugs
  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. aminosalicylate sodium Dihydrofolate reductase inhibitor
  3. anagrelide Antineoplastic and immunomodulating agents (L01)
  4. apremilast Antineoplastic and immunomodulating agents (L04)
  5. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  6. axitinib Antineoplastic and immunomodulating agents (L01)

Related patents

Browse patents Pfizer Australia Pty Ltd patent hub

  1. US 12246064

    Method of treating Crohn's disease by administering a triple combination therapy of anti-integrin antibody, adalimumab and methotrexate

    Expires Mon Mar 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 12005060

    Ophthalmic formulations of methotrexate

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12005061

    Ophthalmic formulations of methotrexate

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 11911385

    Methotrexate treatment methods

    Expires Mon Feb 22 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 11253604

    Conjugate of methotrexate and peptide

    Expires Mon Feb 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 10028911

    Sustained release formulation of methotrexate as a disease-modifying antirheumatic drug (DMARD) and an anti-cancer agent

    Expires Mon Jul 19 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 9770414

    Sustained release formulation of methotrexate as a disease-modifying antirheumatic drug (DMARD) and an anti-cancer agent

    Expires Mon Sep 21 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 8865728

    Combinations comprising methotrexate and DHODH inhibitors

    Expires Mon Oct 16 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 8501766

    Treatment of rheumatoid arthritis with a combination of laquinimod and methotrexate

    Expires Mon Aug 01 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. CA 2742910

    THERAPIE DE COMBINAISON COMPRENANT UN INHIBITEUR DE DHODH ET DU METHOTREXATE POUR TRAITER UNE MALADIE AUTO-IMMUNE

    Expires Thu May 09 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is methotrexate?

methotrexate (ARX-METHOTREXATE) is a dihydrofolate reductase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for methotrexate?

ARX-METHOTREXATE is a marketed brand name for methotrexate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of methotrexate?

methotrexate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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